Fighting Against Age Discrimination in Clinical Trials
Fighting Against Age Discrimination in Clinical Trials
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DOI：
10.1111/j.1532-5415.2010.03032.x
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发表时间：
2010-09-01
影响因子：
6.3
通讯作者：
Michel, Jean-Pierre
中科院分区：
文献类型：
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作者：
Cherubini, Antonio;Del Signore, Susanna;Michel, Jean-Pierre
在美国老年医学会2008年年会上，欧盟老年医学会和美国老年医学会这两个老年医学会以及美国食品和药物管理局和欧洲药品管理局这两个监管机构的代表进行了圆桌讨论，旨在审查老年人参与临床试验的情况。本文总结了会议讨论的重要问题。从历史上看，监管机构在 20 世纪 80 年代末开始推动老年参与者参与临床试验。确定延迟将老年参与者纳入临床试验的原因，以及对纳入患有多种合并症的老年参与者的持续偏见，对于帮助老年科医生对抗临床试验中的年龄歧视非常重要。为了克服这个问题，老年医学会和监管机构必须共同努力提出新的定义、研究设计和技术，旨在改善对患有多种合并症和多重用药的老年人的药物评估。
At the American Geriatrics Society 2008 Annual Meeting, representatives of two geriatric societies, the European Union Geriatric Medicine Societies and the American Geriatrics Society, and two regulatory agencies, the U.S. Food and Drug Administration and the European Medicine Agency, conducted a roundtable discussion aimed at reviewing the participation of older people in clinical trials. This article summarizes the important issues discussed at the meeting. Historically, regulatory agencies started to promote the inclusion of older participants in clinical trials in the late 1980s. The identification of the causes of delay in including older participants in clinical trials, as well as of the ongoing bias against including older participants with multiple comorbidities, is important to help geriatricians fight against age discrimination in clinical trials. To overcome this problem, geriatrics societies and regulatory agencies must work together to propose new definitions, study designs, and technologies aimed at improving the evaluation of drugs in older people with multiple comorbidities and polypharmacy.